Regulatory Analyst - Colombes, France - Oracle

Oracle

Entreprise vérifiée

Colombes, France

il y a 2 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

Regulatory Analyst-230002PV

Applicants are required to read, write, and speak the following languages: English

Preferred Qualifications

Cerner Enviza an Oracle Company is a leading global healthcare consulting firm and trusted advisor to many of the world's top pharmaceutical, biotech, and medical device & diagnostic companies.

By supporting the work of Cerner Enviza an Oracle Company, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research.

Cerner Enviza is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind.

Leading through innovation, we consistently challenge ourselves to discover and embrace new and creative ways to deliver exceptional insight for clients.

Together we leverage a diverse network of providers and data, expert research capabilities and actionable analytics to bring remarkable clarity to life sciences' most important decisions.

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.

Thanks to our Business growth Cerner Enviza is looking for a Regulatory Analyst for the Non-Interventional Studies (NIS) domain.

You will join a team of experts in regulatory and ethics submissions of clinical research studies. You will focus on facilitating the start of research projects while taking a step further in your professional career.

You will be surrounded by passionate colleagues in an open and engaging environment.

MISSION
Prepare clinical research submission dossiers for Competent Authorities and Ethics Committees

Communicate with Competent Authorities, Ethics Committees, project teams and vendors on regulatory-related matters

Maintain the regulatory project documentation flow

Manage safety reporting to authorities, when applicable

Support the regulatory and study team on feasibility assessment and business development requests

Assist in regulatory surveillance and regulatory development tools

Qualifications:

Qualifications:

College/University degree or an equivalent combination of education, training, and experience;
At least 1 year of prior experience with clinical research submissions, including informed consent documents;
Knowledge of clinical research regulations and guidelines that govern clinical research is preferred;
Full working proficiency in English and French;
Detail-oriented;
Advanced knowledge of Microsoft Word, Excel, and PowerPoint;
Excellent planning, organizational and problem-solving skills;
Excellent communication skills - able to distill issues, manage client expectations and act as a trusted advisor in a timely manner;
Ability to work effectively in a team in a fast-paced and dynamic environment;

Detailed Description and Job Requirements
Responsible for conducting applied research in scientific area of focus.

Investigating applicable solutions through rigorous, protracted studies and ensuring that a quality, integrated solution is delivered in a timely manner, at budget, and to our client*s satisfaction.

This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery.

Entry-level position for those who are new to consulting and are developing their expertise.

Receives detailed instruction on routine work and is responsible for performing basic experiments and test on research topic and documenting results.

As a member of a project team, follows standard practices and procedures to evaluate and analyze data, develop reports and presentations in external customer engagements.

Uses available tools to analyze and solve problems for clients. May perform other duties as assigned.

Bachelors or Advanced degree in a discipline relevant to area of focus, plus 1 year related work experience
Minimum

Qualifications:
At least 4 years Total combined related work experience and completed higher education. Depending on the job there may be additional minimum requirements and/or preferred qualifications

Job:
Consulting

Location:
FR-FR,France-COLOMBES CEDEX

Job Type:
Regular Employee Hire

Organization:
Oracle